RECENT MAJOR CHANGES

• Indications and Usage, Macular Edema Following Retinal Vein Occlusion (RVO) (1.2), 6/2010
• Dosage and Administration, Macular Edema Following Retinal Vein Occlusion (RVO) (2.3), 6/2010
• Warnings and Precautions, Thromboembolic Events (5.3), 6/2010

INDICATIONS AND USAGE

LUCENTIS is indicated for the treatment of patients with:

• Neovascular (Wet) Age‑Related Macular Degeneration (AMD) (1.1)
• Macular Edema Following Retinal Vein Occlusion (RVO) (1.2)

DOSAGE AND ADMINISTRATION

FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY (2.1)

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

• LUCENTIS 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month(approximately 28days) (2.2).
• Although less effective, treatment may be reduced to one injection every three months after the first four injections if monthly injections are not feasible. Compared to continued monthly dosing, dosing every 3 months will lead to an approximate 5‑letter (1‑line) loss of visual acuity benefit, on average, over the following 9 months. Patients should be treated regularly (2.2).

Macular Edema Following Retinal Vein Occlusion (RVO)

• LUCENTIS 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days). In the RVO clinical studies, patients received monthly injections of LUCENTIS for six months. In spite of being guided by optical coherence tomography and visual acuity re-treatment criteria, patients who were then not treated at Month 6 experienced on average, a loss of visual acuity at Month 7, whereas patients who were treated at Month 6 did not. Patients should be treated monthly (2.3).

DOSAGE FORMS AND STRENGTHS

• 10 mg/mL solution in a single-use vial for intravitreal injection (3)

CONTRAINDICATIONS

• Ocular or periocular infections (4.1)
• Hypersensitivity (4.2)

WARNINGS AND PRECAUTIONS

• Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored during the week following the injection (5.1).
• Increases in intraocular pressure have been noted within 60 minutes of intravitreal injection (5.2).

ADVERSE REACTIONS

• The most common adverse reactions (reported more frequently in LUCENTIS-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure, and intraocular inflammation (6.2).

To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.